Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions

The goal of this research study is to learn how middle and high school students react to an interactive website called ASPIRE ( A Smoking Prevention Interactive Experience) and health information online and what their preferences are when using ASPIRE.

Researchers hope to use the results of this study to design more effective online health programs to provide middle and high school students with up-to-date information about tobacco use, meditation, and general health and well-being.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation; Tobacco Prevention
• Intervention / Treatment: Behavioral: Surveys; Behavioral: ASPIRE Website; Behavioral: Follow Up Survey; Behavioral: ASPIRE Text-Based Website

Detailed Description

Participants complete up to 2 separate parts.

Part 1:

For Part 1, participants complete a survey about their mental and physical health and their opinions concerning health information and the internet. The survey takes about 15-20 minutes to complete.

Part 2:

If the results of the survey show eligibility, participants complete Part 2 of the study. For Part 2 participants are randomly assigned (as in a roll of dice) to 1 of 2 study groups. Participants have a 1 in 3 chance of being assigned to receive standard care. Participants have a 2 in 3 chance of being assigned to use the ASPIRE website. This is done because no one knows if one study group is better, the same, or worse than the other group.

If participant assigned to receive standard care, he or she is shown a website that has the same information presented in ASPIRE, but in text form.

Participants in both groups sit in front of a computer and go onto a website. Both the ASPIRE website and the text-based website have been designed for middle and high school students. The ASPIRE website has videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. The text-based website only has health information facts about smoking, the benefits of meditation, and healthy living. Participants complete 3 to 4 sessions using either the ASPIRE website or the text-based website throughout their first semester. Each session lasts about 40 minutes.

The use of the websites will be videotaped.

Follow-Up Surveys:

Participants complete a follow-up survey about their opinions concerning health information and the internet immediately after they complete their last session on the website. The follow-up surveys take about 15 minutes to complete.

Length of Study:

Active participation on this study is over after participants complete the follow-up survey. If participant does not continue onto Part 2 of the study, their active participation is over after they complete Part 1 of the study.

Other Information:

Participants take part in this study at their school during their after school program.

During the use of the website, each study participant is individually videotaped and audio recorded. The videotapes and audio recordings are used to help the research staff analyze each participant's use of the websites. The video tapes and audio recordings are stored on a password-protected encrypted hard drive that is stored in a locked office at MD Anderson. Only the study researcher and authorized members of the research staff are allowed to use the videotapes and audio recordings (for research purposes).

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77008
      • Mt. Calvary Baptist Church
    • Houston, Texas, United States, 77253
      • Young Men's Christian Association (YMCA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ages 11 through 18 (11 and 18 included)
2. High school and Middle School students are both eligible
3. All 150 are nonsmokers. Nonsmokers are defined as individuals who have not smoked, not even part of a cigarette in the past year.
4. All will score above the median on smoking susceptibility
5. 10 will be White/Caucasian participants, 5 will be African American participants, 10 will be Hispanic participants, and 5 will be Asian participants.
6. English speaking

Exclusion Criteria:

1)None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASPIRE Group; Participants complete baseline survey. Participants view the ASPIRE website containing videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. This viewing will be videotaped and audio recorded. 3 to 4 sessions will be completed. After each website session, survey will be completed.	Behavioral: Surveys; At baseline participants complete survey about their mental and physical health and their opinions concerning health information and the internet. The survey will take about 15-20 minutes to complete.; Other Names: Questionnaires; Behavioral: ASPIRE Website; Participants view the ASPIRE website containing videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. This viewing will be videotaped; Behavioral: Follow Up Survey; Participants complete a follow-up survey about their opinions concerning health information and the internet immediately after they have completed their last session on the website.; Other Names: Questionnaire
Active Comparator: Control Group; Participants complete baseline survey. Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living. This viewing will be videotaped and audio recorded. 3 to 4 sessions will be completed. After each website session, survey will be completed.	Behavioral: Surveys; At baseline participants complete survey about their mental and physical health and their opinions concerning health information and the internet. The survey will take about 15-20 minutes to complete.; Other Names: Questionnaires; Behavioral: Follow Up Survey; Participants complete a follow-up survey about their opinions concerning health information and the internet immediately after they have completed their last session on the website.; Other Names: Questionnaire; Behavioral: ASPIRE Text-Based Website; Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intention to Smoke	This outcome is measured using the validated susceptibility to smoke scale in a Likert scale format and baseline and immediate follow up.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Response	Outcome measured using validated Likert scales. In addition, facial expressions of happiness, sadness, disgust, fear, anger, and surprise are measured using a software program of emotion recognition for facial movement. The software captures the extent of expression of each of the emotions on a scale from 0 to 1.	4 days
Participants' Reported Qualitatively Attributes in ASPIRE	Participants' reported qualitatively attributes (i.e. features) in ASPIRE that they recall to be emotionally involving. This report conducted using open-ended questions.	1 day
Relationship Between Emotional Involvement During Use of ASPIRE Website and Change in Susceptibility to Smoking	Generation of emotional expression during use of ASPIRE is dependent on data for use of ASPIRE features, and data for emotional expression. Recorded videos of participant's online behavior analyzed via manual content analysis. Recorded videos of online behavior (i.e. mouse movement on the screen, clicking, dragging behaviors, and what the webpage presents) also analyzed using N-vivo.	1 day

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Alex Prokhorov, MD, PhD, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• Khalil GE, Wang H, Calabro KS, Mitra N, Shegog R, Prokhorov AV. From the Experience of Interactivity and Entertainment to Lower Intention to Smoke: A Randomized Controlled Trial and Path Analysis of a Web-Based Smoking Prevention Program for Adolescents. J Med Internet Res. 2017 Feb 16;19(2):e44. doi: 10.2196/jmir.7174.

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Questionnaires; Surveys; Tobacco Prevention; ASPIRE Website; Focus Groups; Health Interactive Website
• Other Study ID Numbers: 2013-0296

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No